BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CRIT-LINE MONITOR III (CLM III)

    K Number: K992227 · Decision Jul 30, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    17
    Applicant Total
    8
    Review Days
    28

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    Basic Information

    Device Name
    CRIT-LINE MONITOR III (CLM III)
    K Number
    K992227
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    In-Line Diagnostics Corp.
    Date Received
    July 2, 1999
    Decision Date
    July 30, 1999
    Product Code
    MQS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQS System, Hemodialysis, Access Recirculation Monitoring

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    Other Clearances by In-Line Diagnostics Corp.

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    K983551 CRIT-SCAN II MONITOR
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    K953875 CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)
    K950942 CRIT-LINE HEMATOCRIT ALERT
    K935958 CRIT-LINE BLOOD CHAMBER WITH E-BEAM